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Trial record 3 of 14 for:    22186789 [PUBMED-IDS]

Phase II FANG™ in Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01453361
Recruitment Status : Terminated (Business Decision to pursue other indications)
First Posted : October 17, 2011
Results First Posted : May 10, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Melanoma
Intervention Biological: Vigil™ Vaccine
Enrollment 18
Recruitment Details This study recruited patients with Stages IIIc and IV melanoma.
Pre-assignment Details 18 were enrolled but 10 screen-failed so only 8 proceeded with the single group assignment (Vigil treatment).
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description

Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.

Vigil™ Vaccine

Period Title: Overall Study
Started 18
Completed [1] 2
Not Completed 16
Reason Not Completed
Disease Progression             6
Screen-Failures             10
[1]
"Completed" means subject had successful Vigil manufacturing and had been given all the doses.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description

Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.

Vigil™ Vaccine

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 18 participants
0-15 Years
0
   0.0%
16-64 Years
9
  50.0%
65 and Older Years
9
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
6
  33.3%
Male
12
  66.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
White/Caucasian
18
 100.0%
Black/African American
0
   0.0%
Asian
0
   0.0%
Hispanic
0
   0.0%
Other
0
   0.0%
1.Primary Outcome
Title Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
Hide Description To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until EOT (30 days after last dose).
Time Frame Baseline, End of Treatment (30 days after last dose) up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects were consented but only 8 subjects were administered Vigil treatment (10 screen-failed). 7 completed treatment (ELISPOT done) while 1 subject died soon after baseline (ELISPOT not done). After 12 months, 7 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description:

Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.

Vigil™ Vaccine

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
ELISPOT Positive After 12 months
7
  38.9%
ELISPOT Negative After 12 months
0
   0.0%
Not Done/Died immediately after Baseline
1
   5.6%
Not Done/Screen-Failed
10
  55.6%
2.Secondary Outcome
Title Number of Alive Subjects
Hide Description The survival status in patients with stages IIIc and IV melanoma treated with Vigil™ vaccine was determined by following these patients up to 3 years.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
18 subjects were consented but only 8 were administered Vigil treatment (10 screen-failed). These 8 subjects were followed for survival up to 3 years after Vigil treatment.
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description:

Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.

Vigil™ Vaccine

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Alive Subjects After 3 years
1
   5.6%
Dead Subjects After 3 years
7
  38.9%
Screen-Failed
10
  55.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vigil™ Vaccine
Hide Arm/Group Description

Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.

Vigil™ Vaccine

All-Cause Mortality
Vigil™ Vaccine
Affected / at Risk (%)
Total   15/18 (83.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vigil™ Vaccine
Affected / at Risk (%) # Events
Total   3/18 (16.67%)    
Gastrointestinal disorders   
Abdominal Hernia  1 [1]  1/18 (5.56%)  1
Infections and infestations   
Soft Tissue Infection  1 [2]  1/18 (5.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor Pain  1 [3]  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Skin Ulceration  1 [4]  1/18 (5.56%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Incarcerated Abdominal Hernia
[2]
Infection of Left Great Toe
[3]
Sacral Nerve Compression secondary to Metastatic Melanoma
[4]
Hemorrhage from tumor nodule
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vigil™ Vaccine
Affected / at Risk (%) # Events
Total   3/18 (16.67%)    
General disorders   
Injection Site Reaction  1  3/18 (16.67%)  9
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Gradalis, Inc.
Phone: 2144428124
EMail: info@gradalisinc.com
Layout table for additonal information
Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT01453361     History of Changes
Other Study ID Numbers: CL-PTL 114
First Submitted: August 10, 2011
First Posted: October 17, 2011
Results First Submitted: February 15, 2018
Results First Posted: May 10, 2018
Last Update Posted: May 24, 2018